Formulation and Drug Delivery

CURE Pharmaceutical Receives Patent for Oral Thin Film Technology

July 24, 2019

Cure Pharmaceutical secured a patent that lets the company load higher drug amounts to its proprietary drug delivery system, CUREfilm.

Catalent Extends Spray Drying Capabilities in Europe

July 16, 2019

An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.

The Native Antigen Company Appoints Biozol and Shanghai Bioleaf as Distributors

July 12, 2019

The Native Antigen Company has revealed its appointment of Biozol and Shanghai Bioleaf as its distributors in Germany, Switzerland, Austria, and China

FDA Releases Draft Guidance on Using the Inactive Ingredient Database

July 10, 2019

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

Guidance on the Harmonization of Compendial Standards Published

July 10, 2019

FDA released draft guidance on using the USP pending monograph process in the drug application process.

CHMP Issues Positive Opinion for Self-Administration of Fasenra

July 02, 2019

AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).

FDA Revamps Biosimilar Quality Requirements

July 02, 2019

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

Proposed Rule Designed to Open Biosimilar Competition

July 02, 2019

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

Considerations for Sterile Filtration of Biologic Drugs

July 02, 2019

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

Gene Therapies Propel Outsourcing Investment

July 02, 2019

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.